The United States
Food and Drug Administration (USFDA) has licensed the drug to Eli Lilly and
Company, an American pharmaceutical company headquartered in Indianapolis,
is a condition that occurs primarily in
diabetic patients that is characterized by a rapid fall in blood sugar levels
below the normal range. Hypoglycemia is a medical emergency in patients with
Type-1 or Type-2 diabetes. The hallmarks of hypoglycemia are altered mental
and/or physical functioning, which requires immediate medical attention for
recovery. In the absence of prompt treatment, it can lead to potentially
life-threatening complications such as loss of consciousness,
coma and even death.
is available as a compact, portable,
ready-to-use pack that doesn't require to be reconstituted. It has a single
fixed dose of 3 mg powdered glucagon in the form of a nasal spray. The drug is
absorbed directly through the nasal mucosa and therefore doesn't need to be
inhaled. Also, it doesn't need to be refrigerated and can be kept at ambient
temperatures (~30ΊC). Baqsimi
is recommended in severe cases of hypoglycemia in diabetic adults and
children aged 4 years and above.
works by stimulating the liver to release
stored glucose into the bloodstream, which increases the blood sugar level. Its
mechanism of action involves binding of glucagon with the glucagon receptors
present in the liver. This stimulates gluconeogenesis, which is a metabolic
process in which glucose is synthesized from non-carbohydrate precursors such
as lactate, pyruvate and glucogenic amino acids. This newly synthesized glucose
is rapidly released from the liver, thereby raising the blood sugar levels.
This is essentially the exact opposite action of
lowers blood sugar levels.
has several advantages over injectable
glucagon, which was approved by the USFDA way back in 1960. These advantages
are well articulated by Dr. Janet Woodcock, MD, who is the Director of USFDA's Center
for Drug Evaluation and Research (CDER) at Silver Springs, Maryland, USA.
"People who are living with diabetes are at risk of
their blood sugar levels falling below the normal range. There are many
products on the market for those who need insulin, but until now, people
suffering from a severe hypoglycemic episode had to be treated with a glucagon
injection that first had to be mixed in a several-step process,"
said Woodcock. "This new way to administer glucagon may
simplify the process, which can be critical during an episode, especially since
the patient may have lost consciousness or maybe having a seizure. In those
situations, we want the process to treat the suffering person to be as simple
Clinical Trials of Baqsimi
were carried out both in adults and children, which are briefly highlighted
Adult Clinical Trials:
Two clinical trials
were carried out in adults, which included 83 and 70 adults, respectively. The
safety and efficacy of Baqsimi
nasal powder were evaluated head-to-head against injectable glucagon for
treating insulin-induced hypoglycemia, using a single dose of each drug.
efficacy to injectable glucagon in adults, with a 100 percent success rate in
case of both drug formulations. The incidence of side-effects, which included
headache, nausea, vomiting, and upper respiratory tract irritation, were
similar in both cases.
Pediatric Clinical Trials:
A clinical trial
was carried out in children aged 4 years to <17 years. The clinical trial
compared the safety and efficacy of Baqsimi
and injectable glucagon. Both drugs exhibited a 100 percent success rate
in elevating blood sugar levels, which was similar to that observed in adults.
The incidence of side-effects was similar in both cases.
Contraindications for Baqsimi
should not be taken in the following
- Pheochromocytoma (rare adrenal
gland tumor that secretes epinephrine and norepinephrine hormones)
- Insulinoma (insulin-secreting pancreatic
tumor derived from β-cells)
- Hypersensitivity to glucagon
- Allergy to any excipients in Baqsimi
- Prolonged fasting
- Chronic hypoglycemia
- Adrenal insufficiency
Side Effects of Baqsimi
Some of the major
side-effects include the following:
- Upper respiratory tract irritation
- Nasal congestion / discomfort
- Epistaxis (bleeding from the nose)
- Rhinorrhea (runny nose)
- Redness of the eyes
- Watery eyes
- Itchy eyes/nose
Besides the common
side-effects listed above, glucagon has also been known to cause anaphylactic
shock (an extreme life-threatening allergic reaction) with breathing
difficulties and hypotension
(low blood pressure)
FDA approved drug
can help treat
severe hypoglycemia without an injection. The drug is delivered nasally and
results in rapid elevation of blood sugar levels.
- FDA approves first treatment for severe hypoglycemia that can be administered without an injection - (https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-severe-hypoglycemia-can-be-administered-without-injection)